Cleared Traditional

K910282 - MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910282 · Graphic Controls Corp. · Obstetrics & Gynecology device
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Mar 1991
Decision
65d
Days
Class 2
Risk

K910282 is an FDA 510(k) clearance for the MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Graphic Controls Corp. devices

Submission Details

510(k) Number K910282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1991
Decision Date March 29, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 160d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFM Monitor, Uterine Contraction, External (for Use In Clinic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.